a study of folfoxiri plus cetuximab vs. folfoxiri plus bevacizumab

Conditions: Colorectal Cancer

Summary: this study is to verify the advantage of folfoxiri plus cetuximab over folfoxiri plus bevacizumab as the first-line therapy in metastatic colorectal cancer patients with ras wild-type tumors.

this study is to verify the advantage of folfoxiri plus cetuximab over folfoxiri plus bevacizumab as the first-line therapy in metastatic colorectal cancer patients with ras wild-type tumors. in this study the investigators employed deepness of response as a primary endpoint.

Eligibility criteria:
inclusion criteria: * histologically confirmed colorectal cancer * ras wild-type * measurable lesion by recist (ver.1.1) * no past history of chemotherapy in the case of unresectable primary lesion/distant metastasis/lymph node metastasis.in the case of recurrence, no treatment for the first recurrence lesion after operation * eastern cooperative oncology group (ecog) performance status 0-1.the case \>=71 years is ps0. * life expectancy of more than 6 months * patients have enough organ function for study treatment within 14 days before enrollment; 1. white blood cell (wbc)\>=3,000/mm3, \<12,000/mm3. 2. neu\>=1,500/mm3. 3. platelet count (plt) \>=10.0x104/mm3. 4. hb\>=9.0g/dl. 5. total bilirubin\<=1.5x upper limited normal (uln) 6. aspartate aminotransferase (ast) \<=2.5xuln. 7. alanine aminotransferase (alt) \<=2.5xuln. 8. creatinine\<=1.5xuln. 9. proteinuria\<=1+. 10. prothrombin time-international normalized ratio (pt-inr) \<=1.5 * must be able to swallow tablets * written informed consent exclusion criteria: * synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval * lynch syndrome * brain metastases * infectious disease * interstitial lung disease or pulmonary fibrosis * comorbidity or history of serious heart failure * history of thromboembolic events * cerebrovascular disease * history of hemoptysis/hematemesis * uncontrolled hypertension (systolic bp\>180mmhg, or diastolic bp\>100mmhg) * sensory alteration or paresthesia interfering with function * large quantity of pleural, abdominal or cardiac effusion * severe comorbidity (renal failure, liver failure, hypertension, etc) * prior radiotherapy for primary and metastases leision * men/women who are unwilling to avoid pregnancy * women who are pregnant or breastfeeding * women with a positive pregnancy test * history of severe allergy * hbsag positive or active viral hepatitis * administration of blood products/ granulocyte-colony stimulating factor (g-csf), and blood transfusion within 14 days * surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgery within 28 days * systematic administration of antiplatelet drug or non steroid anti-inflammatory drugs (nsaids) * diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy * history of gastrointestinal perforation within 1 year * unhealed traumatic bone fracture * uncontrolled diarrhea * history of organ recipient * prior cetuximab/bevacizumab/irinotecan/oxaliplatin treatment (adjuvant therapy by oxaliplatin is excluded) * administration of atazanavir sulfate * jaundice * ileus or bowel obstruction * clinical diagnosis of alzheimer's disease * insulin dependent diabetes * thyroid disease * any other cases who are regarded as inadequate for study enrollment by investigators

Keywords: folfoxiri bmab cmab